Single use lancet assembly

ABSTRACT

A single use lancet assembly having a housing, with an open interior and a piercing aperture defined therein, a lancet, with a body and a piercing tip positioned in the open interior of the housing and movable between a cocked orientation and a piercing orientation, a driving assembly structured to move the lancet into the piercing orientation, and a single use trigger assembly structured to actuate an actuating mechanism thereby allowing the lancet to move, at least temporarily, from its cocked orientation to its piercing orientation. The single use trigger assembly is structured such that it may not be positioned to actuate the actuating mechanism more than one time, thereby preventing inadvertent or intentional re-use of a contaminated piercing tip.

CLAIM OF PRIORITY

The present application is a continuation-in-part application ofpreviously filed, now pending application having Ser. No. 10/134,996,filed on Apr. 29, 2002, which claims priority under 35 U.S.C. Section119(e) to provisional patent application having Ser. No. 60/312,196 anda filing date of Aug. 14, 2001, both of which are incorporated herein byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a single use lancet assembly which issubstantially compact, yet effective for piercing a patient's finger orother body part to obtain a blood sample. The single use lancet deviceis further configured to be substantially safe, preventing re-use of thedevice after it has been actuated, by way of a single use triggerassembly that is structured to assure that subsequent use of acontaminated lancet tip cannot occur. Additionally, the assembly is costeffective and is fully disposable after a single use.

2. Description of the Related Art

Lancets are commonly utilized instruments which are employed both inhospitals and other medical facilities, as well as by privateindividuals, such as diabetics, in order to prick or pierce a patient'sskin, typically on a finger of a patient, thereby leading to thegeneration of a blood sample which can be collected for testing. Becauseof the wide spread use of such lancets, there are a variety of lancetdevices which are available for utilization by patients and/orpractitioners in a variety of different circumstances.

For example, a typical lancet may merely include a housing with a sharppiercing tip that is pushed into the patient's skin. More commonly,however, lancet devices, which house a piercing tip and/or a lancet,have been developed which effectively encase and fire the lancet intothe patient's skin, thereby eliminating the need for the person takingthe sample to actually push the lancet tip into the skin.

Within the various types of specialized lancet devices, one variety aretypically configured for multiple and/or repeated uses, while anothercategory is particularly configured for single use, after which theentire device is disposed of. Looking in particular to the single use,disposable lancet devices, such devices typically include a housingwhich contains and directs or drives a piercing tip into the patient'sskin, and which is disposed of along with the used lancet. Naturally, soto make such disposable devices cost effective for frequent use, suchdevices tend to be rather simplistic in nature providing only asufficient mechanism for firing, and not overly complicating the designso as to minimize that cost.

While existing single use devices are generally effective for achievingthe piercing of the skin required for effective operation, such singleuse, disposable devices typically do not incorporate a large number ofsafety features to assure the safe use and disposal of the device. Forexample, one primary area of safety which must be addressed with alllancet devices pertains to the purposeful and/or inadvertent reuse of acontaminated lancet. Unfortunately, most currently available single uselancet devices are configured such that after a use thereof has beenachieved, it is possible for a patient to re-cock the device, therebyallowing for a subsequent, inappropriate use.

As a result, it would be highly beneficial to provide a single uselancet device which is substantially compact and disposable, can bemanufactured in a substantially cost effective manner, and whichnevertheless is substantially safe to utilize by affirmativelypreventing re-use once contaminated. Additionally, while other devicesmay be provided which prevent a lancet from being re-cocked, it would beextremely desirable to provide an assembly which prevents re-use even ifthe assembly is re-cocked.

SUMMARY OF THE INVENTION

The present invention relates to a single use lancet assembly configuredto pierce a patient's skin and is useable one time only, therebypreventing reuse of a contaminated lancet piercing tip. In particular,the present single use lancet assembly includes a housing having an openinterior and a piercing aperture defined therein. The housing ispreferably compact and includes a lancet disposed within its openinterior.

Looking to the lancet, it is preferably of the type which includes abody and a piercing tip. It is the piercing tip which includes thepointed configuration structured to penetrate or pierce a patient's skinfor the drawing of blood. Moreover, the lancet is cooperatively disposedwithin the open interior of the housing such that the lancet may movebetween at least a cocked orientation and a piercing orientation whereinthe patient's skin is penetrated by the piercing tip.

Also operatively associated with the lancet is a driving assembly. Thedriving assembly is structured to move or drive the lancet, at leasttemporarily, into its piercing orientation from its cocked orientation.Preferably, however, the lancet assembly is configured such that thelancet is generally maintained in its cocked orientation untilaffirmatively released by a user. Along these lines, the single uselancet assembly of the present invention also includes a triggerassembly operatively associated with an actuating mechanism. The triggerassembly is disposed to be exteriorly actuatable from an exterior of thehousing and is positionable to facilitate release of the actuatingmechanism. When the lancet is in its cocked orientation, the actuatingmechanism maintains the lancet in position until it is actuated, such asby pushing a portion of the actuating mechanism into the open interiorof the housing and/or by disengaging the trigger assembly. When thelancet is released from its cocked orientation, the driving assemblypropels the lancet at least temporarily into its piercing orientationwherein the piercing tip protrudes through the piercing aperture of thehousing and, preferably, into the skin of the user.

In order to assure that the lancet assembly is used one time only, thetrigger assembly of the present invention further preferably includes atrigger lock. The trigger lock is configured to prevent the triggerassembly from returning to an actuatable orientation after the triggerassembly has released the lancet from its cocked orientation. As such,by immobilizing the trigger assembly, re-use of the lancet is preventedthus assuring that inadvertent or intentional contact with acontaminated lancet by a user or another person does not occur.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature of the present invention,reference should be had to the following detailed description taken inconnection with the accompanying drawings in which:

FIG. 1 is a side cross section view of one embodiment of the single uselancet assembly of the present invention in an unused, initiallyun-cocked orientation;

FIG. 2 is a side cross section view of the single use lancet assembly ofFIG. 1 illustrating a cocked orientation;

FIG. 3 is a side cross section view of the single use lancet assembly ofFIG. 1 after movement into a piercing orientation from the cockedorientation;

FIG. 4 is a front cross section view of the single use lancet assemblyof FIG. 1 along 4-4 thereof;

FIG. 5 is a side cross section view of an alternate embodiment of thesingle use lancet assembly of present invention after movement into apiercing orientation;

FIG. 6 is a side cross section view of yet another alternate embodimentof the single use lancet assembly of present invention after movementinto a piercing orientation; and

FIG. 7 is a side cross sectional view of an alternate, preferredembodiment of the single use lancet asset assembly of the presentinvention after movement into the piercing orientation.

Like reference numerals refer to like parts throughout the several viewsof the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

As shown throughout the Figures, the present invention is directedtowards a single use lancet assembly, generally indicated as 10. Inparticular, the single use lancet assembly 10 of the present inventionincludes a housing, generally indicated as 20. The housing 20 ispreferably substantially small and compact, and may be made of one or aplurality of segments, preferably of a generally rigid, disposablematerial, such as plastic. The housing 20 includes an at least partiallyopen interior 28 and at least one piercing aperture 22 defined therein.In addition, the lancet assembly 10 of the present invention alsocomprises a lancet, generally indicated as 30, therein.

In particular, the open interior 28 of the housing 20 is preferablysized and configured to effectively receive the lancet 30. The lancet 30preferably includes a body 32 and a piercing tip 34. The piercing tip 34is used to pierce a person's skin so as to draw blood to be utilized fora medical sample and/or test procedure. Moreover, the body 32 may be theshaft of the piercing tip 34 and/or an additional structure such as thatdepicted in the Figures. Regardless, however, the lancet 30 isstructured to move within the open interior 28 of the housing 20,preferably at least between a cocked orientation, such as that depictedin the embodiment of FIG. 2, and a piercing orientation wherein thepiercing tip 34 of the lancet 30 at least temporarily protrudes throughthe piercing aperture 22.

Looking to FIG. 4, movement of the lancet 30 through the housing 20 ispreferably maintained in a substantially linear path by a guideassembly. In the illustrated embodiment, the guide assembly includes atleast one guide ridge 33 protruding from the; body 32 of the lancet 30,and at least one corresponding guide track 25 structured to movablyreceive the guide ridge 33 therein. The guide track 25 preferablyextends at least partially along a length of the open interior 28 of thehousing 20 so as to maintain the guide ridge 33 effectively thereinduring a necessary range of motion of the lancet 30. As depicted in FIG.4, preferably a pair of guide ridges 33 are disposed on opposite sidesof the lancet body 32, with a corresponding pair of oppositely disposedguide tracks 25 being defined in the housing. It is of course, however,understood that the guide tracks 25 need not necessarily be directlydefined in the housing 20, but may be defined by additional elementssecured therein, and conversely the guide track(s) 25 may be defined inor on the lancet body 32, with the guide ridge(s) 33 extending inwardlyfrom the housing 20.

Looking in further detail to the illustrated lancet assembly 10, and thepath of movement of the lancet 30 within the housing 20, when the lancetassembly 10 is initially obtained for use, the lancet 30 can bepre-cocked or maintained in an initially un-used and un-cockedorientation, as best seen in FIG. 1. In this initially un-used andun-cocked orientation a protective cover 40 may extend into the openinterior 28 of the housing 20 so as to at least partially and removablycover the piercing tip 34 of the lancet 30, thereby maintaining thesafety and sterility of the piercing tip 34 when not being used. In thisregard, the protective cover 40 may be formed from a variety ofpreferably rigid materials and is structured to protrude from thehousing 20. Furthermore, the protective cover 40 may include an enlargedhead 42 configured to facilitate grasping thereof and may be molded withor separate from the remainder of the lancet.

In order to effectively retain, and subsequently release, the lancet 30from its cocked orientation, the single use lancet 10 of the presentinvention further includes an actuating mechanism. A variety ofdifferent actuating mechanisms may be incorporated to effectively retainthe lancet 30 in its cocked orientation, however, as illustrated in FIG.2, one embodiment utilizes an actuating mechanism 50 which is secured,either directly or indirectly, to the lancet 30 and is also structuredto engage at least a portion of the housing 20. In addition, theactuating mechanism 50 is actuatable permitting the release of a drivingassembly 38 from a compressed orientation. As such, the actuatingmechanism 50 of the present invention is structured to be both cockedand actuated, one time only, by a trigger assembly, generally shown as60.

In a preferred embodiment of the present invention, the trigger assembly60 is structured such that it can cock and actuate the actuatingmechanism 50 one time only. Additionally, the trigger assembly 60preferably includes a cocking member 67 which cooperatively associateswith a cocking surface 52 of the actuating mechanism 50, wherein thecocking member 67 is structured to engage the cocking surface 52 andmove the lancet 30 from its initial un-used orientation to its cockedorientation, as illustrated in FIG. 2, by selectively positioning atrigger 64. It is also recognized, however, that the cocking surface 52may define the actuating mechanism 50, the lancet being maintained onlymomentarily cocked by the trigger assembly itself prior to release.

In the illustrated embodiment, the actuating mechanism 50 furtherincludes an actuating surface 54 structured to be at least temporarilypositioned into an actuation aperture 24 when the lancet 30 is in itscocked orientation. Furthermore, the actuating mechanism 50 isstructured to generally restrict movement of the lancet 30 from itscocked orientation, at least partially defined by the actuating surface54 positioned into the actuation aperture 24, effectively retaining thelancet 30 in its cocked orientation. Specifically, the actuatingmechanism 50 extends from the body 32 of the lancet 30 along a biasingportion 56 terminating at the actuating surface 54, and at least aportion of the actuating mechanism 50 abuts an interior surface 26 ofthe housing 20 within the actuation aperture 24, thereby preventingmovement of the lancet 30 from its cocked orientation, as illustrated inFIG. 2. When, however, the actuating mechanism 50 is actuated, forexample, by pushing the actuating surface 54 down into the open interior28 of the housing 20, the abutting engagement is released and the lancet30, is permitted to freely move within the housing 20 into its piercingorientation, at least temporarily. As mentioned, although the precedingdefines the illustrated actuating mechanism 50, it is understood that avariety of alternative actuating mechanisms 50, such as those includingseparate elements to retain and to release the lancet 30 may also beprovided, and/or including structures which are actually part of thedriving assembly 38, may also be provided.

In an alternate, less preferred embodiment of the present invention, theprotective cover 40 may be structured to allow the user to move thelancet 30 into its cocked orientation by pushing the enlarged head 42toward the housing 20, as depicted by the arrow in FIG. 1, therebypositioning the actuating surface 54 into the actuation aperture 24.Once in the cocked orientation, the protective cover 40 may be removedfrom the piercing tip 34, for example, by a twisting thereof, therebyleaving the piercing tip 34 completely exposed for use.

The single use lancet of the present invention further includes thedriving assembly, generally indicated as 38. The driving assembly 38 isparticularly configured to move the lancet 30 at least temporarily intoits piercing orientation wherein the piercing tip 34 protrudes throughthe piercing aperture 22 of the housing 20 a desired amount. Inparticular, if desired, a depth adjustment structure could be positionedat the piercing aperture 22 to control the amount which the piercing tipprotrudes from the housing 20. For example, a threaded washer typeelement could be adjustably secured to the housing 20 in generallysurrounding relation to the piercing aperture 22.

Looking further to the driving assembly 38, preferably the drivingmovement occurs when the lancet 30 is released from its cockedorientation. In the illustrated embodiment, the driving assembly 38includes a biasing element operatively disposed between the lancet 30and the housing 20. Moreover, in the illustrated embodiment, a spring ispreferably utilized as the biasing element, however, it is recognizedthat a variety of other driving assemblies may be utilized, including awedge assembly, a hammer type assembly and/or a resilient materialplate, segment or extension, all of which may be configured to move thelancet 30 from its cocked orientation into its piercing orientation.Further, it is preferred that based upon the size of the housing 20 andthe nature and size of the driving assembly 38, that after the lancet 30has moved into its piercing orientation wherein the piercing tip 34 atleast temporarily protrudes through the piercing aperture 22, the lancet30 tends to be retracted back into the housing 20, as best illustratedin FIG. 3. As a result, the used piercing tip 34 is effectivelyconcealed within the housing 20 subsequent to usage, protecting againstinadvertent or intentional engagement between the user or another personand the used piercing tip 34. Indeed, it is recognized that a secondbiasing element may be positioned in from of the lancet 30 so as todrive it back into the housing after it has passed into the piercingorientation.

As previously mentioned, the present invention preferably includes asingle use trigger assembly 60 structured to both cock and actuate theactuating mechanism 50 one time only. The trigger assembly 60 isdisposed to be exteriorly actuatable, and in the illustrated embodimentssubstantially on the exterior of the housing 20, and is positionable tofacilitate cocking and subsequent actuation of the actuating mechanism50, as illustrated throughout the Figures. In order to facilitateselective positioning of the trigger assembly 60, the present inventionpreferably comprises at least one trigger guide 62 which engages a pivotpoint of the trigger 64. In an alternate embodiment, a pair of triggerguides 62 may engage the pivot point of the trigger 64. The triggerguides 62 may be integral to the trigger 64 such as, by way of exampleonly, tabs molded directly with or onto the trigger 64. Alternatively,the trigger guides 62 may be separate components, such as cylindricalaxles which operatively engage the pivot point of the trigger 64. Thetrigger guides 62 are structured such that the trigger 64 is selectivelyand slidingly positionable along a trigger track 65 disposed on thehousing 20. The trigger track 65 may be formed as an integral componentof the housing 20, as illustrated throughout the Figures, or, in analternate embodiment, the trigger track 65 may be a separate componentmounted to an external surface 27 of the housing 20.

In order to actuate the trigger assembly 60, the actuation member 68 ispositioned into alignment with the actuation aperture 24, such as whilethe lancet 30 is in its cocked orientation as in the embodiment of FIG.2, or merely when the trigger assembly 60, and therefore the lancet 30in the case of the illustrated embodiments, have been sufficientlyretracted. A rearward force is applied to the upwardly extending portionof the trigger 64 causing the actuation member 68 to move downward intoengagement with the actuating surface 54 pushing the actuating mechanism50 into the open interior 28 of the housing 20, thereby permitting thedriving assembly 38 to move the lancet 36, at least temporarily, fromits cocked orientation into its piercing orientation and/or releasingthe engagement by the trigger assembly.

In order to assure that the lancet assembly 10 of the present inventionis used one time only, the trigger assembly 60 further comprises atrigger lock 66. In one preferred embodiment, the trigger lock 66 isdisposed along the cocking member 67 of the trigger assembly 60.Additionally, the trigger lock 66 comprises at least one, but preferablya pair of locking members 69 which are positioned along the sides of thecocking member 67 in an upwardly outward extending configuration, asillustrated in FIGS. 1 through 4. The locking members 69 are normallydisposed in the open interior 28 of the housing 20 below the triggertrack 65, prior to the actuation of the trigger assembly 60. However,upon actuation of the trigger assembly 60, the downward force applied tothe trigger 64, as described above, pivots the trigger 64 along itspivot point thereby pulling the cocking member 67 upward and at leastpartially out of the housing 20, and consequently pulling the lockingmembers 69 upward into the trigger track 65, as illustrated in FIG. 3.Due to the laterally outward extending configuration of the lockingmembers 69, once they are positioned within the trigger track 65, thelocking members 69 cannot be repositioned back into the open interior 28of the housing 20, thereby preventing the cocking member 67 and theactuation member 68 from being returned to their respectivepre-actuation orientations. In an alternative configuration, the lockingmembers 69 may be disposed along the cocking member 67 such that uponactuation of the trigger assembly 60, the locking members 69 are pulledupward and completely out of the housing 20, wherein their laterallyoutward extending configuration prevents the cocking member 67 and theactuation member 68 from returning to their respective pre-actuationorientations.

An alternate embodiment of the present invention includes a trigger lock66′ having a locking member 69′ positioned along a rearward portion ofthe actuation member 68. The locking member 69′ may comprise a generallywedge shape configuration, wherein upon positioning of the actuationmember 68 into the actuation aperture 24, a portion of the lockingmember 69′ engages an interior surface 26 of the housing 20, asillustrated in FIG. 5, thus preventing removal of the actuation member68 from the open interior of the housing, thereby eliminating thepossibility of re-actuation of the actuating mechanism 50. In onevariation of this embodiment, the locking member 69′ may be inwardlybailable while positioning the actuation member 68 through the actuationaperture 24, thereafter returning to a normally outwardly biasedposition engaging the interior surface 26 of the housing 20. In anothervariation of this embodiment, the locking member 69′ may be structuredto positively engage a notch or groove in the interior surface 26 of thehousing 20.

Yet another alternate embodiment of the present invention includes afirst locking member 70 which is positioned on the underside of thetrigger 64 between the actuation member 68 and the pivot point, facingthe housing 20, as illustrated in FIG. 6. Upon actuation of the triggerassembly 60, the first locking member 70 operatively engages a secondlocking member 70′ which is disposed on an exterior surface 27 of thehousing 20 thereby immobilizing the trigger assembly 60 and preventingits movement into an actuating orientation. One of either the firstlocking member 70 or the second locking member 70′ may be structured tobe at least temporarily biased into a compressed configuration so as topermit entry through an aperture of the other member, thereafterreturning to an unbiased, expanded configuration so as to prevent itsremoval from the aperture of the other member.

In addition to the trigger lock 66, once the actuation member 68 hasbeen positioned through the actuation aperture 24, the actuation member68 may prevent cocking of the lancet 30, even by manual utilization ofthe protective cover 40 as described above, due to the presence of theactuation member 68 in the actuation aperture 24. At least oneembodiment of the present invention may comprise an actuation member 68which is structured so as to allow the lancet 30 to be re-cocked afteractuation, via a partially notched portion on the actuation member 68,as illustrated in FIG. 5. However, re-cocking the lancet 30 afteractuation only serves to further assure that the used piercing tip 34does not inadvertently or intentionally contact the user or anotherperson by locking the lancet 30 in place within the housing 20, becauseit cannot be re-actuated since the trigger assembly 60 is locked andimmobilized after only one use.

Indeed, looking to a preferred embodiment of FIG. 7, the, recessedregion defined by the inwardly extending lip 75 on the actuation member68 may serve to define a lock member and thereby the trigger lock.Specifically, the lip 75 may be configured to extend sufficiently inwardsuch that after the lancet 30 has retracted from its piercingorientation, the actuating mechanism 50 will engage the lip 75 andprevent the actuation member 68 from being retracted so as to permitfurther actuation of the trigger assembly 60. Of course, in such anembodiment the actuation member 68 may or may not function to releaselancet from its cocked orientation. Alternately, the angle of theactuation member 68 may be such that after it releases the lancet, arotational movement thereof results in the lip 75 engaging the abutmentsurface 26, that engagement preventing movement of the trigger assembly60 back into a pre-fired orientation.

Since many modifications, variations and changes in detail can be madeto the described preferred embodiment of the invention, it is intendedthat all matters in the foregoing description and shown in theaccompanying drawings be interpreted as illustrative and not in alimiting sense. Thus, the scope of the invention should be determined bythe appended claims and their legal equivalents.

Now that the invention has been described,

1. A single use lancet assembly comprising: a housing, said housingincluding an at least partially open interior and a piercing aperturedefined therein; a lancet, said lancet including a body and a piercingtip; said lancet disposed in said open interior of said housing andstructured to move at least between a cocked orientation and a piercingorientation; a trigger structured to position said lancet into saidcocked orientation and to release said lancet from its cockedorientation; and a driving assembly structured to move said lancet atleast temporarily into said piercing orientation; said trigger furtherincluding a trigger lock structured to at least partially immobilizesaid trigger within at least a portion of said housing after said lancethas been released one time, thereby preventing repositioning of saidtrigger to a pre-actuation orientation and preventing re-firing of saidlancet; and said trigger lock including at least one locking memberconnected to a cocking member of said trigger assembly and structured toengage a trigger track thereby preventing repositioning of said triggerto a pre-actuation orientation after said lancet has been affirmativelyreleased one time.
 2. A single use lancet as recited in claim 1 whereinsaid driving assembly includes a biasing element operatively disposedbetween said lancet and said housing.
 3. A single use lancet as recitedin claim 2 wherein said biasing element comprises a spring.
 4. A singleuse lancet as recited in claim 1 wherein said trigger is structured toat least temporarily protrude from said housing when said lancet isdisposed in said cocked orientation.
 5. A single use lancet as recitedin claim 1 further comprising an actuating mechanism structured toengage said lancet and abut an interior surface of said housing so as toretain said lancet in said cocked orientation until said lancet isaffirmatively released.
 6. A single use lancet as recited in claim 1wherein said trigger lock comprises a pair of said locking members.
 7. Asingle use lancet as recited in claim 1 further comprising an actuatingmechanism disposed between said lancet and said housing and structuredto prevent said lancet from moving out of said cocked orientation untilaffirmatively released.
 8. A single use lancet as recited in claim 7wherein said actuating mechanism comprises an actuating surface and isfurther structured to abut an interior surface of said housing therebypreventing said lancet from moving out of said cocked orientation untilaffirmatively released.
 9. A single use lancet as recited in claim 8wherein said actuating mechanism comprises a biasing portion extendingfrom said lancet.
 10. A single use lancet as recited in claim 9 whereinsaid trigger is structured to at least partially engage said actuatingsurface and push said actuating mechanism into said open interior ofsaid housing thereby affirmatively releasing said lancet from saidcocked orientation.
 11. A single use lancet as recited in claim 1further comprising a protective cover structured to at least partiallyand removably cover said piercing tip of said lancet at least prior tomovement of said lancet into said cocked orientation.
 12. A single uselancet as recited in claim 11 wherein said protective cover isstructured to protrude through said piercing aperture of said housingand is further structured to be pushed into said housing by a user so asto position said lancet into said cocked orientation.
 13. A single uselancet assembly comprising: a housing, said housing including an atleast partially open interior and a piercing aperture defined therein; alancet, said lancet including a body and a piercing tip; said lancetdisposed in said open interior of said housing and structured to move atleast from a cocked orientation to a piercing orientation; a triggerstructured to at least position said lancet into said cockedorientation; an actuating mechanism secured to said lancet andstructured to abut an interior portion of said housing thereby retainingsaid lancet in said cocked orientation until affirmatively released;said trigger further structured to at least partially engage anactuating surface on said actuating mechanism and push said actuatingmechanism into said open interior of said housing thereby affirmativelyreleasing said lancet from said cocked orientation; and a drivingassembly structured to move said lancet at least temporarily into saidpiercing orientation; said trigger including a trigger lock structuredto at least partially immobilize said trigger assembly within at least aportion of said housing after said lancet has been affirmativelyreleased one time thereby preventing repositioning of said trigger to apre-actuation orientation; and said trigger lock including at least onelocking member connected to a cocking member of said trigger assemblystructured to engage a trigger track thereby preventing repositioning ofsaid trigger to a pre-actuation orientation after said lancet has beenaffirmatively released one time.
 14. A single use lancet as recited inclaim 13 wherein said trigger lock comprises a pair of locking members.15. A single use lancet as recited in claim 13 further comprising aprotective cover structured to at least partially and removably coversaid piercing tip of said lancet at least prior to movement of saidlancet into said cocked orientation.
 16. A single use lancet as recitedin claim 15 wherein said protective cover is structured to protrude fromsaid piercing aperture of said housing and is structured to be pushed bya user so as to position said lancet into said cocked orientation.